Tuesday, 23 December 2014

FDA Approves Combo Hepatitis C Treatment

Dec. 22, 2014 -- The U.S. Food and Drug Administration on Friday approved a new combination treatment for people with chronic hepatitis C virus infection, which can lead to advanced liver disease without treatment.

The drug, Viekira Pak, includes a pill containing three antiviral drugs (ombitasvir, paritaprevir and ritonavir) along with a dasabuvir pill. All but ritonavir are new.

"The new generation of therapeutics for hepatitis C virus is changing the treatment paradigm for Americans living with the disease," said Dr. Edward Cox, director of antimicrobial products in the FDA's Center for Drug Evaluation and Research, in an agency news release.

The Centers for Disease Control and Prevention estimates 3.2 million Americans are infected with hepatitis C, a viral disease that can lead to cirrhosis or liver cancer if untreated.

Viekira Pak -- marketed by Chicago-based AbbVie -- can be used with or without ribavirin, another drug often prescribed for hepatitis C patients. But Viekira Pak is not recommended for patients with advanced cirrhosis, the FDA said.

In six clinical trials evaluating Viekira Pak, the most common side effects reported were fatigue, itching, feeling weak, nausea and trouble sleeping, the FDA said.

In the past 13 months, the FDA has approved three other drug products to treat chronic hepatitis C infection: Olysio (simeprevir), Sovaldi (sofosbuvir) and Harvoni (ledipasvir and sofosbuvir).